On April 22, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported selection of a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous non-small cell lung cancer (NSCLC), based on adverse event profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1.1 (Press release, Ideaya Biosciences, APR 22, 2024, View Source [SID1234642219]).

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"We are excited to select a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous NSCLC, based on AE profile and multiple responses observed at this dose. We believe MTAP-deletion squamous NSCLC is an area of high unmet medical need, and we are excited to further evaluate clinically our potential first-in-class MAT2A inhibitor IDE397 in this tumor setting, while in parallel advancing multiple rational combinations with our pharma collaborators and internal wholly owned pipeline," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

"We believe IDE397 is well positioned as a potential first-in-class MAT2A inhibitor and encouraged to see preliminary translation of our preclinical activities to the clinic in the MTAP-deletion squamous NSCLC setting. Next, through this year we look forward to the potential to clinically validate several important preclinical hypotheses we have generated on several mechanistically high conviction rational combinations in the MTAP-deletion setting," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. The Company continues to focus on evaluating IDE397 in two trials, including as monotherapy and in multiple clinical combinations:

IDE397-001 (NCT04794699) is a Phase 2 monotherapy expansion of IDE397 in MTAP-deletion solid tumors
Phase 1/2 trial of IDE397 + AMG 193 in MTAP-Deletion NSCLC (Amgen-sponsored study, NCT05975073)
Phase 1 trial of IDE397 + Trodelvy in MTAP-deletion bladder cancer (IDEAYA-sponsored, NCT04794699)

On April 22, 2024 OSR Holdings, a global healthcare holding company, reported that it has signed a memorandum of understanding (MOU) with SillaJen, a Kosdaq-listed biotech firm with a pipeline of immuno-oncology drug candidates, to share technology and clinical development resources and launch a strategic collaboration between the two companies (Press release, OSR Holdings, APR 22, 2024, View Source [SID1234642218]). Through the MOU, the two companies will explore various ways to collaborate to create synergies between current platform technologies and new drug candidates.

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OSR Holdings was established in 2019 in South Korea as a "hub-and-spoke" business model, which has become more visible in the biopharma space over the past decade. The "hub-and-spoke" model, exemplified by companies like Roivant Sciences, PureTech Health and BridgeBio Pharma, enables centralized management of drug development strategies, clinical plans, and resource allocation by the holding company. The model allows the holding companies’ subsidiaries to concentrate on the advancement of new drug assets and technological innovations. The model’s scalability and resource efficiency are notably enhanced, especially as clinical phases of drug development progresses.

OSR Holdings’ current portfolio includes Vaximm AG, a Swiss entity developing immuno-oncology therapeutics; Darnatein, a South Korean drug developer of osteoarthritis therapeutics; and RMC, a distributor of specialized medical devices. Vaximm AG, a venture spun out from Merck KGaA, has completed Phase 2a clinical trials for glioblastoma. Darnatein, established by Dr. Seung-Hyun Choi, a former researcher at one of the leading research institutes in the U.S., Salk Institute for Biological Studies, boasts a robust platform for cartilage and bone regeneration and is developing new drugs for other diverse disease indications based on this foundational technology.

SillaJen boasts a diverse pipeline of new drugs, including the SJ-600 series and BAL0891, and is leading the way in developing anti-cancer viruses based on its GEEV platform. Known for its immune-evasion capabilities, GEEV enables anti-cancer viruses to efficiently target affected areas. The SJ-600 series is an anti-cancer pipeline based on SillaJen’s GEEV platform. BAL0891, a mitotic checkpoint inhibitor, has advanced to Phase 1 clinical trials targeting solid tumors and will be conducted in the United States.

Sung Jae "Alex" Yu, COO of OSR Holdings, stated, "the signing of this MOU marks the two companies transitioning into strategic partners for the development of innovative drug technologies in the global immuno-oncology market. We eagerly anticipate exploring a variety of opportunities to further our relationship and collaborations with SillaJen, particularly in the U.S., the largest pharmaceutical market in the world."

A representative of SillaJen stated, "We can anticipate synergies by collaborating between a company that possesses original anti-cancer drug development technology and a company with global business expertise," and added, "Aside from our cooperation with existing partners, we will have the opportunity to present SillaJen’s exceptional pipeline in the U.S. market."

On April 22, 2024 Biohaven Ltd. (NYSE: BHVN), a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology, reported the closing of its underwritten public offering of 6,451,220 of its common shares, which includes the full exercise of the underwriters’ option to purchase 841,463 additional common shares, at a public offering price of $41.00 per share (Press release, Biohaven Pharmaceutical, APR 22, 2024, View Source [SID1234642217]). The gross proceeds from the offering were approximately $264.5 million before deducting underwriting discounts and commissions and offering expenses payable by Biohaven. Biohaven intends to use the net proceeds received from the offering for general corporate purposes.

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J.P. Morgan, Morgan Stanley, TD Cowen, and Piper Sandler & Co. acted as the joint lead book-running managers of the offering. Cantor acted as a book-runner of the offering. Baird also acted as a book-runner of the offering.

The offering was made only by means of a prospectus supplement and the accompanying prospectus, copies of which may be obtained from the offices of the following: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected], Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected], and Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected].

The shares were issued pursuant to an effective shelf registration statement on Form S-3. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.

On April 22, 2024 Replicate Bioscience, a clinical-stage company pioneering novel self-replicating RNA (srRNA) technology for use in infectious disease, oncology, autoimmune disease, and more, reported acceptance of two oral presentations at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, May 7-11 in Baltimore, Maryland (Press release, Replicate Bioscience, APR 22, 2024, View Source;cell-therapy-asgct-annual-meeting-302123737.html [SID1234642216]).

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Presentation Details:

The full abstracts are now available through the ASGCT (Free ASGCT Whitepaper) conference website.

Title: Novel Self-Replicating RNA Vectors Broaden Therapeutic Window and Expand Use Outside of Vaccines
Session Title: Emerging Viral Vectors
Location and Time: Ballroom 4, Thursday, May 9, 5:15 PM – 5:30 PM ET
Abstract: 204
Presenter: Parinaz (Paris) Aliahmad
Summary: Ultra-low doses of optimized srRNA vectors achieved immunization with protective antibody titers with minimal reactogenicity in a preclinical influenza model. This broadened therapeutic window presents the opportunity to use these vectors for many clinical applications.

Title: Single and Low Dose Self-Replicating RNA Vaccine Provides Effective Immune Protection Against Rabies in Healthy Volunteers
Session Title: Vector Product Engineering, Development, and Manufacturing (excluding AAV)
Location and Time: Room 314-317, Saturday, May 11, 10:15 AM – 10:30 AM ET
Abstract: 408
Presenter: Zelanna Goldberg
Summary: RBI-4000, an srRNA vector encoding the rabies glycoprotein encapsulated in a lipid nanoparticle, is the first clinical demonstration of next-generation srRNA technology. Interim analysis of a Phase 1 trial demonstrate that all doses were well tolerated and that RBI-4000 was immunogenic at all dose levels tested, conferring protection with a single, low dose.

On April 22, 2024 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported the acceptance of two abstracts at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 Annual Meeting being held May 7-11, 2024, in Baltimore, MD (Press release, Carisma Therapeutics, APR 22, 2024, View Source [SID1234642214]).

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"We are excited to present new preclinical data highlighting the potential of our engineered macrophage cell therapies for the treatment of liver and lung fibrosis, both of which represent significant unmet medical needs with limited available therapies for patients," said Michael Klichinsky, PharmD, PhD, Co-founder and Chief Scientific Officer of Carisma. "We look forward to presenting these data and are excited to expand our macrophage engineering platform beyond oncology."

Poster Presentation Details:

Title: Genetically Engineered Macrophage Cell Therapy Reverses Liver and Lung Fibrosis in Preclinical Models
Abstract #: 852
Session: Other Cellular and Regenerative Therapies
Date & Time: Wednesday, May 8, 2024; 12:00 PM ET
Location: Exhibit Hall

Title: Redirected Soluble Modulators (RSM) – A Novel Engineering Strategy to Enhance Immune Receptor Signaling
Abstract #: 812
Session: Immune Targeting and Approaches with Genetically-Modified Cells and Cell Therapies
Date & Time: Wednesday, May 8, 2024; 12:00 PM ET
Location: Exhibit Hall

The posters presented at ASGCT (Free ASGCT Whitepaper) 2024 will be available online in the "Publications" section of Carisma’s website at View Source following the start of the respective poster sessions.